- Any acute or chronic adverse effects of prior therapy have resolved to
determined by CTCAE v4.0 criteria

- Laboratory values at screening:

- Absolute neutrophil count ≥ 1,500 /mm3;

- Platelets ≥ 100,000 /mm3;

- Hemoglobin ≥ 9.0 g/dL;

- Total bilirubin ≤ 1.5 times the upper limit of normal;

- AST (SGOT) ≤ 2.5 times the upper limit of normal;

- ALT (SGPT) ≤ 2.5 times the upper limit of normal;

- Serum creatinine ≤ 2 times the upper limit of normal;

Exclusion Criteria:

- Pregnancy or lactation. Women of childbearing potential must have a negative serum
pregnancy test within 7 days prior to enrolment. Male and female patients of
childbearing potential must agree to use appropriate birth control (barrier methods
with spermicides, oral or parenteral contraceptives and/or intrauterine devices)
during the entire duration of the study, or the patient must be surgically sterile
(with documentation in the patient's medical records)

- Persistent QTc >450 ms for males, or >470 ms for females, according to Fridericia's
correction

- Patients with Grade 3 or greater hyponatremia at screening

- History of Class III or IV congestive heart failure according to New York Heart
Association (NYHA) classification

- History of another malignancy, except for non-basal-cell carcinoma of skin or
carcinoma-in-situ of the uterine cervix, and not disease free ≥5 years

- History or presence of central nervous system (CNS) metastasis or leptomeningeal
tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or
neurological exam

- History of human immunodeficiency virus infection

- Presence of active, uncontrolled infection

- Radiotherapy received within 4 weeks prior to baseline

- Use of any investigational agents within 4 weeks of baseline

- Major surgery within 4 weeks prior to baseline

- Receipt of radiotherapy to >25 % of bone marrow

- Concomitant treatment with, or anticipated use of, pharmaceutical or herbal agents
which are potent inhibitors or inducers of cytochrome P450 enzymes (Appendix D1),
unless approved by the Sponsor

- Uncontrolled intercurrent illness that would jeopardize patient safety, or interfere
with the objectives of the protocol, or limit patient compliance with study
requirements, as determined by the Investigator

NCT ID:

Start Date:

Completion Date:

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